Final answer:
Records of drug samples must be kept to monitor their long-term storage stability and post-preparative conditions. Detailed documentation is required following NDA approval to track adverse drug experiences, emphasizing the critical nature of these records.
Step-by-step explanation:
When it comes to long-term storage of drug samples, records should be meticulously kept to ensure samples remain viable and that any changes or degradation can be adequately traced. These records are crucial for ensuring short-term stability at room temperature or sample processing temperature, as well as post-preparative stability under the storage conditions used during the study. For example, factors like the freeze-thaw cycle may affect the sample's stability and need to be accurately documented for quality control. Additionally, once a drug receives NDA approval, the sponsor is required to report adverse drug experiences to the FDA, which underscores the importance of maintaining detailed records of drug samples throughout their lifecycle.